FDA Jobs in Minnesota

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Sr. Principal Statistics

PARAKEET WORLD SOLUTIONS LLC

•

Remote

Contract

Job Title: Sr. Principal StatisticsLocation: Remote Duration: 6 MonthsEmployment Type: W2 ContractExperience Level: Mid-SeniorEducation Required: Ph.D. or MS in Statistics or BiostatisticsIndustry: Pharmaceuticals Job Summary:The Sr. Principal Statistician will lead statistical activities in clinical trials, from protocol development to final study reporting. The role will also contribute to regulatory filings, in-licensing evaluations, and marketing support. Key Responsibilities:Review protocol
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Posted 15 days ago

Engineer Disposables R&D, Sustaining

Stefanini

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Plymouth, Minnesota, USA

Contract

Stefanini Group is hiring! Stefanini is looking for Engineer - Disposables R&D, Sustaining in Plymouth, MN (Hybrid) For quick Apply, please reach out to Vipul Bhardwaj - call: / email: Work Hours: M-F (40 hours) Work Location: Plymouth, MN (Hybrid) Shift: 1st Shift Create new 3rd party supplier documentation including design specifications, labeling, design drawings, etc. for peritoneal dialysis disposable sets.Create, modify, and maintain design history files.Perform change control assessments.
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Posted 12 days ago | Updated 2 hours ago

Principal Engineer Disposables R&D, Sustaining

Stefanini

•

Plymouth, Minnesota, USA

Contract

Stefanini Group is hiring! Stefanini is looking for Principal Engineer - Disposables R&D, Sustaining in Plymouth, MN (Hybrid) For quick Apply, please reach out to Tuhin Podder- call: /email: Work Hours: M-F (40 hours) Work Location: Plymouth, MN (Hybrid) Shift: 1st Shift Technical lead for DHF structure within sustaining engineering for disposable medical devices.Manage new 3rd party supplier documentation strategy for peritoneal dialysis disposable sets.Manage change controls from initiation th
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Posted 12 days ago | Updated 2 hours ago

Validation Engineer III

Katalyst Healthcares and Lifesciences

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Mounds View, Minnesota, USA

Full-time

Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Perform, oversee, and guide supplier process validations (IQ/OQ/PQ) for sterile barrier packaging material manufacturing processes. Ensure supplier process validation requirements (CTQs, drawings, specifications, risk levels, and protocols) are communicated, understood, and executed. Collaborate with suppliers to review and approve validation documentation, including prot
Posted 60+ days ago | Updated 7 hours ago

Clinical Data manager

Intone Networks Inc.

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Remote

Contract, Third Party

Need stronger with working on Data Acquisition, DTAs and vendor relations. Responsibilities: Support the planning, setup, and acquisition of external clinical data at the study level, assisting in managing study start-up, conduct, and closeout activities.Assist in creating external data transfer agreements, ensuring alignment with Takeda Standards and specifications to support data integration, analysis, and reporting.Provide support in setting up infrastructure for external data to flow into T
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Posted 5 days ago

JD EDWARD DEVELOPER

Virisha LLC

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Remote

Contract

JD Edwards E1 Developer 100% REMOTE but open to working core CST hours 6 month contract to hire Job Description: PREFERRED QUALIFICATIONS: Experience with JDE 9.2+ and Tools Release 9.2.x.Familiarity with BI Publisher, JDE Security, and Workflow.Experience integrating JDE with third-party systems using REST/SOAP APIs.Background in Agile/Scrum or DevOps environments.DUTIES AND RESPONSIBILITIES: Lead the design, development, and implementation of complex customizations and enhancements in JD Edw
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Posted 1 day ago

Job Title: Product Manager Healthcare Remote

Think Big Solutions, Inc

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Remote

Contract

Job Title: Product Manager Healthcare Location: [City, State or Remote] Job Type: [Full-Time / Part-Time / Contract] Job Summary: We are seeking an experienced and strategic Product Manager with a background in healthcare to lead the development and execution of products that improve patient outcomes, provider workflows, or payer efficiency. The ideal candidate will have a strong understanding of healthcare systems, regulations (e.g., HIPAA, HL7, FHIR), and the complexities of healthcare deliver
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Posted 6 days ago

Sales head

Showman Staffing

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Remote

Full-time

Job Title: Sales Head Experience: 6+yrs Location: Remote-Travel required(100% travel) Job: Permanent Full Time Requirement Role Overview We are seeking a passionate and driven Sales professional to accelerate our growth in the Healthcare and MedTech space one of the most rapidly evolving sectors today. You will work with a high performing team targeting innovative healthcare providers, MedTech firms, and digital health disruptors to bring cutting-edge technology solutions to life. You will repr
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Posted 1 day ago

DTS Lead - Intelligent Clinical Supply Management

Quantum Integrators Group LLC

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Remote or King of Prussia, Pennsylvania, USA

Third Party, Contract

Role Name: DTS Lead - Intelligent Clinical Supply Management (ICSM) Location: King of Prussia, PA. REMOTE 6+ Months contract Job Description The DTS Lead ICSM is responsible for leading the design, implementation, and optimization of SAP's Intelligent Clinical Supply Management (ICSM) solution. This role supports clinical trial operations by ensuring efficient planning, forecasting, packaging, labeling, and distribution of clinical trial materials across global sites, while maintaining regulato
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Posted 9 hours ago

Engineer Disposables and Sustaining

Rose International

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Plymouth, Minnesota, USA

Full-time

Date Posted: 07/11/2025 Hiring Organization: Rose International Position Number: 485371 Industry: Healthcare Job Title: Engineer Disposables and Sustaining Job Location: Plymouth, MN, USA, 55441 Work Model: Onsite Employment Type: Temp to Hire FT/PT: Full-Time Estimated Duration (In months): 12 Min Hourly Rate($): 30.00 Max Hourly Rate($): 35.00 Must Have Skills/Attributes: Creo, DFMEA, Medical device, Sterilization Experience Desired: Experience in Class II or Class disposables medical
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Posted 12 days ago | Updated 3 hours ago

Computer System Validation Analyst - R Studio & Clinical Systems

Katalyst Healthcares and Lifesciences

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Remote or New Jersey, USA

Full-time

Responsibilities: Lead validation planning, risk assessment, and execution for R Studio, GitLab, and Medidata Rave EDC. Develop and execute validation documentation including: Validation Plans (VP.). User Requirements Specifications (URS.). Risk Assessments (RA.). Functional and Design Specifications. Traceability Matrix (RTM.). Test Protocols (IQ/OQ/PQ or CSA-based scripts.). Validation Summary Reports (VSR.). Collaborate with cross-functional stakeholders including Clinical Data Mana
Posted 60+ days ago | Updated 7 hours ago

Senior Commissioning, Qualification & Validation (CQV) Engineer

Johnson & Johnson

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Remote or Athens, Georgia, USA

Full-time

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn m
Posted 3 days ago | Updated 7 hours ago

Sr. Engineer Disposables R&D, Sustaining

Katalyst Healthcares and Lifesciences

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Plymouth, Minnesota, USA

Full-time

Responsibilities: This section contains a list of primary responsibilities of this role that account for 5% or more of the work. The incumbent will perform other duties assigned. Lead and support small to medium sized projects with global cross-functional teams in the implementation of design changes (e.g. new features, suppliers, materials, labeling, CAPA/Client, cost reduction, remediation). Identify, investigate, and solve engineering problems utilizing risk-based and customer focused app
Posted 60+ days ago | Updated 7 hours ago

Principal R&D Engineer

Katalyst Healthcares and Lifesciences

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Plymouth, Minnesota, USA

Full-time

Job Description: This section focuses on the main purpose of the job in one to four sentences. Leads design and development of product changes within sustaining engineering for disposable medical devices. Responsibilities: This section contains a list of primary responsibilities of this role that account for 5% or more of the work. The incumbent will perform other duties assigned. Schedule, budget, and lead engineering projects with minimal guidance. Serve as the technical expert for design
Posted 60+ days ago | Updated 7 hours ago

Principal Software Architect - Clinical Imaging Software (Plymouth, MN or Cambridge, MA)

Philips North America

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Plymouth, Minnesota, USA

Full-time

Job Title Principal Software Architect - Clinical Imaging Software (Plymouth, MN or Cambridge, MA) Job Description Principal Software Architect- Clinical Imaging Software (Plymouth, MN or Cambridge, MA) We are seeking an experienced and visionary Principal Software Architect to lead the architectural direction of our Clinical Imaging Software portfolio for the Image Guided Therapy Devices (IGT-D) business. As a key member of the Software Leadership team, you will be responsible for shaping in
Posted 22 days ago | Updated 7 hours ago

Lead Engineer - MES Opcenter

Katalyst Healthcares and Lifesciences

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Remote or New York, USA

Full-time

Job Description: The Lead Engineer will lead a team of technical resources to design, develop, configure, and test MES (Manufacturing Execution Systems) solutions. They will be directly responsible for leading resources contracted vi third-party and through other Pharmaceutical organizations to develop & deploy MES application software to Medical Device manufacturing sites globally. Responsibilities: Act as subject matter expert on system design and architecture. Solutioning and designing new
Posted 22 days ago | Updated 7 hours ago

Engineer III, Validation

Thermo Fisher Scientific

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Remote or Waltham, Massachusetts, USA

Full-time

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description COMPANY: Thermo Fisher Scientific Inc. LOCATION: 168 Third Avenue, Waltham, MA 02451 TITLE: Engineer , Validation HOURS: Monday to Friday, 8:00 am to 5:00 pm DUTIES: Perform technical diagnosis of operational problems, repairs, and calibrations on a wide range of laboratory equipment to ensure that the equipment is operating to the customer's complete satisfaction and manufacture specifications; Perform techn
Posted 23 days ago | Updated 7 hours ago

Cloud Engineer

ICF

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New Jersey, USA

Full-time

Please note: This role is contingent upon contract award. While it is not an immediate opening, we are actively conducting interviews and extending offers in anticipation of the award. The Work We are seeking a skilled and security-focused Cloud Engineer to support mission-critical systems for our federal government client. The ideal candidate will have experience architecting, deploying, and managing cloud solutions in compliance with government cybersecurity frameworks such as FedRAMP, NIST,
Posted 25 days ago | Updated 7 hours ago

Senior Appian Developer

General Dynamics

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Remote

Full-time

Type of Requisition: Pipeline Clearance Level Must Currently Possess: None Clearance Level Must Be Able to Obtain: None Public Trust/Other Required: Other Job Family: Software Engineering Job Qualifications: Skills: Appian (Platform), Appian BPM, Appian Process Automation Certifications: None Experience: 5 + years of related experience ship Required: No Job Description: General Dynamics Information Technology is seeking numerous candidatesto fill multiple-level Appian Developer roles on
Posted 44 days ago | Updated 7 hours ago

Sr. R&D Engineer

Johnson & Johnson

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Remote or New Brighton, Minnesota, USA

Full-time

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn m
Posted 3 days ago | Updated 7 hours ago